Sterile container



2 Sheets- Sheet 1 TIE .4.

INVENTOR. LZM/GA/T ATTORNEY F. J. KNIGHT STERILE CONTAINER April 12,1966 Filed Aug. 27, 1962 EPA/v03 BY Mdma April 12, 1966 F. J. KNIGHT3,245,567

STERILE CONTAINER Filed Aug. 27, 1962 2 Sheets-Sheet 2 INVENTOR.A'e4/vc/s J Mae/w- BY 1/ M a. W

ATTORNEY United States Patent 3,245,567 STERILE CONTAINER Francis JosephKnight, New Brunswick, N.J., assignor to Johnson & Johnson, acorporation of New Jersey Filed Aug. 27, 1962, Ser. No. 219,435 4Claims. (Cl. 215-42) The present invention relates to sterile containersfor hypodermic syringe needle units and the like, more particularly tosuch containers which are tamper-proof and made up of two basic halves,or parts, which are locked together by mechanical means so that thecontainer can only be opened by breaking a structural element of one ofthe parts.

In the copending application of Charles Castelli, Serial No. 219,492,filed August 27, 1962, a container of this type is disclosed andclaimed. The container of that application comprises a shell having anopen end for receiving a needle unit and a cap for closing the open endof the shell. Locking means presented by the cap are adapted to engagecooperating means on the shell as the cap is placed in position on theshell in such a Way that the cap is locked on the shell against axial orradial movement with respect thereto. The locking means is connected tothe cap by a plurality of thin ribs and the ribs are adapted to breakwhen the cap is twisted with respect to the shell thereby allowing thecap to be removed from the shell. Thus, since access to the contents ofthe container can be obtained only by breaking the ribs, a clearindication is provided as to whether or not the container has beenopened or tampered with.

In the embodiment disclosed in the above-cited Castelli application, thelocking means connected to the ribs comprise wedge shaped detents andthe cooperating means presented by the shell is in the form of aradially extending flange having slots through which the detents arepassed to engage the flange. This means that the detents must beregistered with the slots in the flange in order to assemble the cap onthe shell.

The present invention contemplates a tamper-proof sterile container ofthis general type wherein the locking means on the cap need not beregistered with the cooperating means presented by the shell and, infact, is adapted to be placed in full engagement with the shell merelyby pressing the cap and the shell together regardless of their angulardisposition with respect to one another.

According to the instant invention, a locking ring is connected to aplurality of thin ribs spaced circumferentially about a closure portionof the cap, and a holding rim is presented by the shell for engaging thelocking ring when the cap is in position on the shell. The innerdiameter of the locking ring is less than the outer diameter of theholding rim and the locking ring is prevented from rotating with respectto the holding rim when in position thereon by the engagement occurringbetween the insid surface of the locking ring and the outside surface ofthe holding rim due to the diiferences between their respective innerand outer diameters. Preferably, the inner surface of the locking ringpresents a multiplicity of grooves and teeth running in a generallyaxial direction and the outer surface of the holding rim presents acorresponding number of alternating grooves and teeth running in thesame direction. In this case, the inner diameter of the locking ring andthe outer diameter of the holding rim is measured across the tips oftheir respective teeth and the teeth of the ring are adapted to meshwith the grooves of the rim and vice versa so that the locking ring andthe holding rim are mechanically engaged with one another in such a wayas to prevent relative rotative movement between them when the ring isin position on the rim.

In addition, the locking ring presents a flange portion extendingradially inwardly beyond said holding rim from the leading end of thelocking ring when the cap is in position on the shell. The locking ringis formed of a resilient material and either the locking ring or thehold: ing rim presents an inclined annular surface for creating anonreversible cam action between the leading end of the locking ring andthe holding rim for radially displacing the locking ring outwardly withrespect to the holding rim to allow the flange portion and the remainderof the locking ring to fit over the rim and snap in position thereonafter the flange portion passes completely over the rim.

Thus, the locking ring is prevented from rotating with respect to theholding rim by the engagement occurring between the inside surface ofthe ring and the outside surface of the rim and the ring is preventedfrom moving axially away from the shell by the flange portion .of thering snapped over the holding rim. Therefore, the cap can only beremoved from the shell by twisting the cap with respect to the shellwith sufficient force to break the ribs connecting the locking ring tothe remainder of the cap. When this is done, a positive indication, inthe form of the broken ribs, is provided that the container either hasbeen opened or tampered with.

During the time the cap is in position on the shell, a positive fit ismaintained between the closure portion of the cap and a correspondingportion of the bore of the shell. The outer diameter of the closureportion is greater than the inner diameter of the said correspondingportion of the bore of the shell and the closure portion or the bore ofthe shell presents an inclined annular surface for creating a cam actionfor radially displacing the closure portion with respect to said bore toallow the closure portion to move inside of and provided a resilient fitwith the corresponding portion of the bore. Thus, the closure portion ofthe cap exerts an outward radial force on the bore portion of the shelland the locking ring exerts an inward radial force on the rim of theshell which surrounds the bore. This, in effect, squeezes the 'mouthportion of the shell between the closure portion and the locking ring ofthe cap and assures a positive hermetic seal between the closure portionand the bore of the shell as well as positive mechanical engagementbetween the locking ring and the rim of the shell.

Other and further advantages of this invention will be apparent from thefollowing description and claims taken together with the drawingswherein:

FIG. 1 is a view in elevation of a sterile container for a needle unit,according to one embodiment of the invention;

FIG. 2 is an enlarged top plan view of the container of FIG. 1;

FIG. 3 is enlarged view partly in section and partly in elevation of thecontainer of FIG. 1 showing its contents;

FIG. 4 is an enlarged partial view partly in section and partly inelevation similar to FIG. 3,'bu't showing the cap approaching the sleevejust prior to assembly of the cap on the sleeve;

FIG. 5 is another enlarged partial View partly in section and partly inelevation, taken along the line 55 of FIG. 2, showing the parts of thecontainer of FIG. 4 as the locking ring is being displaced outwardlyduring its motion over the holding rim presented by the sleeve;

FIG. 6 is an enlarged view partly in section and partly in plan takenalong the line 6-6 of FIG. 3 with the contents of the container omittedfor the sake of clarity;

FIG. 7 is an enlarged exploded view in perspective showing the variousparts of the container of the embodiment of FIG. 1;

FIG. 8 is an enlarged sectional view taken along the line 8--8 of FIG.3;

FIG. 9 is an enlarged bottom plan view of the hub of the needle unit ofthis embodiment;

FIG. 10 is an enlarged view partly in section and partly in elevation ofthe open end of the shell of the container of this embodiment with theneedle unit removed for the sake of clarity;

FIG. 11 is a top plan view of the shell of FIG. 10;

FIG. 12 is an enlarged view partly" in section and partly in elevationillustrating the twisting of the cap with respect to the shell to breakthe ribs attaching the body of the cap to the shell through the lockingring on the cap;

FIG. 13 is an enlarged top plan view of the container of FIG. 12illustrating the breaking of the ribs.

Referring to the drawings, there is shown a sterile container accordingto one embodiment of this invention which comprises an elongated hollowshell 21 having a closed front end 22 and a normally open rear enddefining a bore 23 of circular cross section. The bore 23 is adapted toreceive a sterile unit, such as a sterile needle unit 24 comprising ahypodermic needle 25 and its hub 26, and hold it firmly in position. Acap 27 is provided for closing the open end of the shell and fittingtightly therewith to provide a hermetic seal which assures that theneedle unit is completely sealed inside the container and protectedagainst contamination. The cap 27 also is hollow and comprises a hollowbody portion .28 for receiving the rear end 29 of the needle (if adouble ended needle is involved), a closure portion 31 adapted to fittightly in the bore 23 of the shell 21 and a locking ring 32 surroundingthe closure portion and concentric therewith. The locking ring 32 isconnected to the closure portion 28 and the remainder of the cap by aplurality of thin ribs 33, three to be exact, spaced,circumferentiallyabout the closure portion by approximately 120 from one another. Theribs 33 extend radially from the closure portion 31 to the locking ring32 of the cap and it is preferred that their axial dimension beconsiderably greater than their circumferential dimension so that theypossess a tall rectangular cross section. The reason for this willappear more clearly hereinafter.

The shell 21 comprises a holding rim 34 surrounding and substantiallyconcentric with the bore 23 of the shell at the mouth of the shell. Theholding rim 34 extends from the top of the shell to an annular shoulder35 spaced from the top of the shell.

The inner diameter of the locking ring 32 is less than the outsidediameter of the holding rim 34 and the locking ring presents an annularflange portion 36 at its leading end which extends radially inwardlybeyond the holding rim 34 when the cap 27 is in position on the shell 21so that the flange portion 36 of the locking ring is positioned justbelow the shoulder 35at the lower end of the rim.

The flange portion 36-of the locking ring 32 presents an inclinedannular surface 37 for contacting the leading peripheral edge 38 of theholding rim on the shell and causing the flange portion 36 and theremainder of the locking ring 32 to be displaced outwardly with respectto the rim 34 so that the ring can pass over the rim as the cap is beingpositioned on the shell. The inclined annular surface 37 is curved incross section, as shown in FIGS. 3, 4, 5, and 12. However, it could beflat if it is inclined at the proper angle to distend, or displaceoutwardly, the locking ring to allow it to pass over the rim.

Once the locking ring 32 is in position on the holding rim 34, the ringand the rim are prevented from rotating with respect to one another bythe engagement occurring between the inside of the ring and the outsideof the rim due to the differences between their respective inner andouter diameters, and the locking ring is prevented from moving axiallyaway from the shell by the flange portion 36 snapped over the shoulder35 presented at the lowei end of the holding rim. Thus, the cam actionpro vided by the inclined annular inner surface37 of the flange portion36 on the ring 32 is nonreversible since the ring 32 will not distend ifan attempt is made to pull the cap 27 away from the shell 21. The innersurface of the locking ring 32 presents a multiplicity er alternatinggrooves 41 and teeth 42 running in a generally airialdirec tion and theouter surface of the holding riiri 34 presents a corresponding number ofalternating.v grooves and teeth 44, running in the same direction. Theinside diameter of the locking ring and the outside diameter of theholding rim are measured across the tips of their re spective teeth andthe teeth of the rim are adapted to mesh with the grooves of the rim andvice versa, whereby the locking ring 32 and the holding rim 34 aremechanically engaged in such a way as to prevent relative rotativemovement between them when the ring is in position on the rim. I I IThus, to remove the cap 27 from the shell 21, it is necessary to breakthe ribs 33 connecting the ldc'ki'n ring 32 to the remainder of the can.This is acemplishe by twisting the cap with respect to the shell asilliistrated most clearly in FIGS. 12 and 1 3-. To facilitate this, theribs 33 have a thin cross section in a circumferential diree= tion, asmentioned hereinbefore and as shown most clearly in FIGS. 2 and 6.However, they are relatively high,- or thick, in an axial direction togive them sufficient strength to retain their integrity during assemblyof the cap on the shell, as shown most clearly in FIGS. 3-5.,Alternating flutes 45 and ridges 46' are provided on the outside of thebody of the cap 27 and on the outside of the shell 21 below the holdingrim 34 for gripping the capand the shell to allow them to be held duringtwisting for the purpose of breaking the ribs. Once the ribs 33 arebroken, the remainder of the cap 27 may be removed from the shell toprovide access to the contents of the container. Broken rib portions 33aremain attached to the locking ring and the remainder of the cap andprovide clear evidence that the. container either has been opened ortampered with, thereby providing a tamperproof container.

A relatively large number of the alternating grooves 41 and 43 and teeth42 and 44 are provided on the inner surface of the locking ring 32 andthe outer surface of the holding rirn 34, respectively, so that, as thering snaps on the rim after the ring has been distended to allow it tomove over the rim, the tips of the teeth 42 on the ring automaticallyenter corresponding grooves 43 on the rim to locate the cap radiallywith respect to the shell. Thus, there is no problem of registering thecap radially with respect to the shell. It is only necessary to move thecap 27 toward the shell 21 as shown in FIG. 4 and press it over theshell so that the ring 32 distends, as shown in FIG. 5, and allows thecap to snap into position once the flange portion 36 of the ring. passesthe shoulder 35 on the rim 34 of the shell. However, once the ring 32 issnapped into position on the rim 34 of the shell, it is impossible torotate the ring with respect to the shell since it is in positivemechanical engagement therewith through the corresponding alter- 'natinggrooves and teeth on the mating surfaces of the ring and the rim.

When the cap 27 is in position on the shell 21, the mouth portion of theshell 21 which presents the bore 23, on the inside, and the rim 34, onthe outside, is

squeezed between the closure portion 31 and the locking ring 32 of thecap, since the outside diameter of the closure portion 31 is greaterthan the inside diameter of the corresponding portion of the bore 23 ofthe shell and, as previously mentioned, the ring 32 must be distended tofit over the rim 34 of the shell. An inclined annular surface 47 ofcurved cross section is presented at the mouth of the bore 23 of theshell for radially displacing the closure portion 31 with respect to thebore 23 to allow the closure portion to move inside of and provide aresilient fit with the corresponding portion of the bore. As a result,when the cap 27 is in position on the shell 21, the closure portion 31exerts an outward radial force on the bore 23 of the shell and thelocking ring 32 exerts an inward radial force on the rim 34 of theshell, thereby assuring, both a positive hermetic seal between theclosure portion and the bore of the shell, and positive mechanicalengagement between the locking ring and the rim of the shell.

In the embodiment of the invention shown in the drawings, the shell 21of the container is adapted to be utilized as a wrench for applying theneedle unit 24 to a hypodermic syringe, not shown, after the cap 27 hasbeen removed from the shell. A sleeve portion 48 of the shell, locatedjust below the open bore 23 thereof, is provided for holding andengaging the hub 26 of the needle unit for this purpose. Both the hub 26and the sleeve portion 48 of the shell possess corresponding noncircularcross sections, shown most clearly in FIG. 8, to prevent relativerotative movement of the hub 26 with respect to the sleeve portion 48 ofthe shell when the needle unit is in position therein. The hub 26comprises alternating flutes 49 and lands 51, i.e., three flutes andthree lands, for this purpose. Threads 52 are provided on the insidesurfaces of the flutes 49 for engaging corresponding threads, not shown,at the front end of a hypodermic needle. The inner surface of the sleeveportion 48 of the shell includes a pair of inwardly projecting, axiallyextending, rectangular teeth 53 for engaging the hub 26 and holding itagainst rotation with respect to the shell 21. The rectangular teeth 53are located diametrically opposite one another on centers angularlyspaced approximately 180 from one another. The alternating flutes 49 andlands 51 each subtend, or extend over, approximately 60 arcs at theoutside surface of the hub and the lands are located diametricallyopposite the flutes. The teeth 53 are appreciably narrower than thelands and the diametric distance between the teeth is less than theouter diameter of the hub measured over the lands. Because of thisarrangement of the flutes 49 and the lands 51 on the huband the size andlocation of the flat teeth 53 extending from the inside surface of thesleeve portion, it is not necessary to register the hub 26 angularlywith respect to the shell 21 when the needle unit is positioned therein.The needle unit 24 need only be inserted in the shell 21 and it willautomatically position itself in the sleeve portion 48 thereof, asillustrated in FIG. 8, in such a way that one of the flat teeth 53 bearsagainst a flute 49 and the other bears against the opposite land 51 ofthe hub of the needle unit. Since the tooth 53 located in the flute 49cannot move angularly beyond the edge of the flute, relative rotation ofthe needle unit with respect to the shell is prevented. The sleeveportion 48 of the shell must be sufficiently flexible and resilient toallow one tooth 53 to fit in the flute 49 and the other to press againstthe opposite land 51 since the teeth are distorted from their normalposit-ions when in these locations.

It will be apparent that both the cap 27 and the shell 21 of thecontainer of this invention should be formed from a relatively resilientyet tough and impermeable material. It is preferred that both the shelland the cap be molded from a resilient plastic material such as polyethylene. The cap should be molded from a material which has thenecessary physical properties to give the ribs 33 suflicient strengthduring assembly of the cap on the shell and sufficient rigidity orbrittleness to facilitate breaking the ribs when the cap is twisted withrespect to the shell to open the container. Therefore, for some designs,it may be advantageous to mold the cap from a material such aspolystyrene.

Having now described the invention in specific detail and exemplifiedthe manner in which it may be carried into practice, it will be readilyapparent to those skilled in the art that innumerable variations,applications, modifications, and extensions of the basic principlesinvolved may be made without departing from its spirit or scope.

The invention claimed is:

1. A sterile container comprising a shell for holding a sterile unit andhaving a normally open end defining a bore of circular cross-section forinsertion of the sterile unit in the shell and removal of the unittherefrom; and a press-on cap adapted to close the open end of the shelland provide a hermetic seal therewith, said cap comprising a closureportion adapted to fit tightly in said bore, a plurality of thin ribsspaced circumferentially about said closure portion and connected at oneend to said closure portion, a locking ring connected to the oppositeends of said ribs, and .a holding rim presented by said shell forengaging said locking ring when said cap is in position on the shell,the normal inner diameter of said locking ring being less than the outerdiameter of said holding rim and said locking ring presenting a flangeportion extending radially inwardly beyond said holding rim when the capis in position on the shell, said locking ring being formed of resilientmaterial and one of said locking ring and said holding rim presenting aninclined annular surface for creating a nonreversible cam action forradially displacing said locking ring outwardly with respect to saidholding rim to allow the flange portion and the remainder of the lockingring to fit over said rim and snap in position thereon, the locking ringbeing prevented from rotating with respect to the holding rim by theengagement occurring between the inside surface of the locking ring andthe outside surface of the holding rim due to the differences betweentheir respective inner and outer diameters and the locking ring beingprevented from moving axially away from the shell by the flange portionsnapped over the holding rim, said ribs being adapted to break when theclosure portion of the cap is rotated by hand with respect to the shell,thereby allowing the closure portion of the cap to be removed from theshell and at the same time indicating that the container has beenopened.

2. A sterile container according to claim 1, wherein the inner surfaceof the locking ring presents a multiplicity of grooves and teeth runningin a generally axial direction and the said outer surface of the holdingrim presents a corresponding number of grooves and teeth running in thesame direction, the said inner diameter of the locking ring and the saidouter diameter of the holding rim being measured across the tips oftheir respective teeth and the teeth of the ring being adapted to meshwith the grooves of the rim and vice versa, whereby the locking ring andthe holding rim are mechanically engaged in such a way as to preventrela tive rotative movement between them when the ring is in position onthe rim.

3. A sterile container according to claim 3 wherein the outer diameterof said closure portion is slightly greater than the inner diameter of acorresponding portion of said bore and one of said closure portion andsaid bore presents an inclined annular surface for creating a cam actionfor radially displacing said closure portion with respect to said boreand allowing the closure portion to move inside of and provide aresilient fit with the corresponding portion of said bore.

4. A sterile container according to claim 3, wherein the mouth portionof the shell presenting the bore on the inside and the rim on theoutside is squeezed between the closure portion and the locking ring ofthe cap, thereby assuring a positive hermetic seal between the closureportion and the bore and positive mechanical engagement between thelocking ring on the cap and the rim on the shell.

References Cited by the Examiner UNITED STATES PATENTS 1,190,708 7/1916Bennett 21542 2,004,050 3/ 1935 Kerk 20643 2,009,097 11/1937 Beider eta1 215-42 3,021,942 2/1962 Hamilton 20643 3,025,989 3/1962 Williams21542 FOREIGN PATENTS 1,134,371 12/1956 France.

913,504 6/ 1954 Germany.

THERON E. CONDON, Primary Examiner.

EARLE I. DRUMMOND, Examiner.

1. A STERILE CONTAINER COMPRISING A SHELL FOR HOLDING A STERILE UNIT AND HAVING A NORMALLY OPEN END DEFINING A BORE OF CIRCULAR CROSS-SECTION FOR INSERTION OF SAID STERILE UNIT IN THE SHELL AND REMOVAL OF THE UNIT THEREFROM; AND A PRESS-ON CAP ADAPTED TO CLOSE THE OPEN END OF THE SHELL AND PROVIDE A HERMETIC SEAL THEREWITH, SAID CAP COMPRISING A CLOSURE PORTION ADAPTED TO FIT TIGHTLY IN SAID BORE, A PLURALITY OF THIN RIBS SPACED CIRCUMFERENTIALLY ABOUT SAID CLOSURE PORTION AND CONNECTED AT ONE END OF SAID CLOSURE PORTION, A LOCKING RING CONNECTED TO THE OPPOSITE ENDS OF SAID RIBS, AND A HOLDING RIM PRESENTED BY SAID SHELL FOR ENGAGING SAID LOCKING RING WHEN SAID CAP IS IN POSITION ON THE SHELL, THE NORMAL INNER DIAMETER OF SAID LOCKING RING BEING LESS THAN THE OUTER DIAMETER OF SAID HOLDING RIM AND SAID LOCKING RING PRESENTING A FLANGE PORTION EXTENDING RADIALLY INWARDLY BEYOND SAID HOLDING RIM WHEN THE CAP IS IN POSITION ON THE SHELL, SAID LOCKING RING BEING FORMED OF RESILIENT MATERIAL AND ONE OF SAID LOCKING RING AND SAID HOLDING RIM PRESENTING AN INCLINED ANNULAR SURFACE FOR CREATING A NONREVERSIBLE CAM ACTION FOR RADIALLY DISPLACING SAIDD LOCKING RING OUTWARDLY WITH RESPECT TO SAID HOLDING RIM TO ALLOW THE FLANGE PORTION AND THE REMAINDER OF THE LOCKING RING TO FIT OVER SAID RIM AND SNAP IN POSITION THEREON, THE LOCKING RING BEING PREVENTED FROM ROTATING WITH RESPECT TO THE HOLDING RIM BY THE ENGAGEMENT OCCURRING BETWEEN THE INSIDE SURFACE OF THE LOCKING RING AND THE OUTSIDE SURFACE OF THE HOLDING RIM DUE TO THE DIFFERENCES BETWEEN THEIR RESPECTIVE INNER AND OUTER DIAMETERS AND THE LOCKING RING BEING PREVENTED FROM MOVING AXIALLY AWAY FROM THE SHELL BY THE FLANGE PORTION SNAPPED OVER THE HOLDING RIM, SAID RIBS BEING ADAPTED TO BREAK WHEN THE CLOSURE PORTION OF THE CAP IS ROTATED BY HAND WITH RESPECT TO THE SHELL, THEREBY ALLOWING THE CLOSURE PORTION OF THE CAP TO BE REMOVED FROM THE SHELL AND AT THE SAME TIME INDICATING THAT THE CONTAINER HAS BEEN OPENED. 